Senior Operational Support Analyst

JOB REQUIREMENTS: Responsibilities Works with departmental staff/management to develop and/or review departmental SOPs for correctness, ease of use and compliance with regulations, policies, and pertinent quality performance standards and expectations. Performs impact analysis, risk assessments and facilitates process analysis and change with operational departments. Utilizes and teaches use of related tools such as flowcharts, FMEA, cause and effect diagrams, RCA, etc. Consults with operational leadership to lead and oversee efficient change control and validation processes. Develops tools and identifies quality indicators to report information related to quality process/function risks within the departments. Develops, oversees and assists departments with tracking audits, proficiency testing results, and incident management documentation. Partners with operations to determine necessary corrective and preventative actions. Leads projects at Versiti level for organizational changes. Prepares and presents project status and special reports as needed. Performs impact assessment and determines product suitability resulting from incident management events. Monitors the effectiveness of changes and corrective actions; coordinates follow-up and participates in system design and implementation to ensure process control. Serves as a resource person for procedural and regulatory issues for the department. Participates in external and internal audits. Supports lot release functions and reviews operational records on a daily, monthly, and quarterly basis as needed. Primary lead for research protocols associated with collecting and testing of blood products. Using Versiti core values, works toward achievement of departmental goals and objectives in support of Versiti's vision and mission. Maintains up-to-date knowledge of quality issues through participation in meetings, task forces, committees and self-directed learning. Upholds and reinforces the customer service standards of Versiti. Participates in creation and delivery of training on a process level. Acts as a partner with the other members of the departments to provide services to customers. Performs other duties as assigned. Performs other duties as assigned Complies with all policies and standards Qualifications Education High School Diploma or equivalent required Bachelor's Degree in science or field related to blood center activities required Experience 4-6 years technical, consultant or managerial experience in a regulated industry where change management, validation and creation of SOPs (standard operation procedures) required Manufacturing experience in a cGMP, ISO (International Organization for Standardization), or equivalent certified environment preferred Experience in development of technical educational material preferred Knowledge, Skills and Abilities Strong organizational skills with excellent verbal and written communication skills that translate across all levels of Versiti leadership required Ability to read, interpret, and functionally apply federal, state, and accrediting agency regulations and determine both direct and indirect impact across functions required Expertise and ability to apply principles and tools of continuous improvement to analyze and improve Blood Services processes required Proven analytical, critical thinking and complex problem-solving skills required Excellent leadership, mentoring and coaching skills required Knowledge of the principles of adult learning techniques and effective training abilities required Demonstrated ability to write technical information in a clear and concise manner required Ability to ensure SOPs (standard operating procedure) are compliant with regulations, policies, and pertinent quality performance expectations required Ability to facilitate large, diverse teams across the organization required Expertise of quality business processes such as current Good anufacturing Practices (cGMPs) and Continuous Improvement (CI) required Tools and Technology Personal Computer (desk top, lap top, tablet) required General office equipment (computer, printer, fax, copy machine) required Computer software including word processing, spreadsheets, databases, statistical analysis tools required ***** APPLICATION INSTRUCTIONS: Apply Online: https://talentwire.org/tZ3bcc Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.